DSD Models at Malawi Sentinel Sites (SENTINEL 2-Malawi) - Trial NCT05901727

Timeline & Enrollment

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.
 
 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, Malawi NHRC
 2376), 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-Malawi 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-Malawi was conducted in 2021. We are now
 amending the protocol to allow up to two additional annual rounds of data collection, in
 2022-2023. We collected clinic aggregate data, conducted surveys of patients and providers,
 and observed operations at a selected set of 12 Malawian healthcare facilities and their
 affiliated DSD models in Round 1. Round 2 and 3 will collect the same types of data at 12
 facilities in Malawi and will expand the study's research questions to include differentiated
 models of HIV testing and linkage to care. Results are expected to inform Malawian 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