NCT05901727

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

Outcomes of Differentiated Models of Service Delivery for HIV Treatment at Sentinel Sites in Malawi (Sentinel-Malawi)

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 15,520 (estimated)
• Sponsor: Boston University · Academic / Other
• Sex: All
• Age: 15 Years
• Healthy volunteers: Not accepted

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, the investigators 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. The investigators are now amending the protocol to allow up to two additional annual rounds of data collection, in 2022-2023. The investigators 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.

Conditions

• HIV

Interventions

Type	Name	Description
OTHER	No intervention	Observational data collection only.

Timeline

• Start date: 2021-06-01
• Primary completion: 2024-12-14
• Completion: 2027-12-01
• First posted: 2023-06-13
• Last updated: 2026-01-27

Locations

1 site across 1 country: Malawi